Prescription drug · ANDA
Abiraterone Acetate NDC 43598-468
Abiraterone acetate 500 mg/1 · Tablet · Oral · Dr. Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-468-38 | 43598046838 | 6 BLISTER PACK in 1 CARTON (43598-468-38) / 10 TABLET in 1 BLISTER PACK (43598-468-79)Marketed from Sep 11, 2023 | |
| 43598-468-60 | 43598046860 | 60 TABLET in 1 BOTTLE (43598-468-60)Marketed from Sep 11, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Abiraterone Acetate
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208416
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-468_5e7f1aec-5727-4e71-1a05-55e8eef89e0aSPL ID 5e7f1aec-5727-4e71-1a05-55e8eef89e0aSPL set ID 7eda0d98-c2ba-c117-b757-1f566292e789RxCUI 1100075, 1918042UNII EM5OCB9YJ6UPC 0343598358048
- Pharmacologic class
- Cytochrome P450 17A1 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443598046838followed by a unit qualifier and the quantityPackage 43598-0468-38. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablet is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208416
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Abiraterone Acetate | Abiraterone acetate 250 mg/1 | TabletOral | Dr. Reddys Laboratories Inc | 43598-358 |
| Abiraterone Acetate | Abiraterone acetate 250 mg/1 | TabletOral | AvPAK | 50268-032 |
| Abiraterone Acetate | Abiraterone acetate 250 mg/1 | TabletOral | NorthStar Rx LLC | 16714-963 |
| Abiraterone Acetate | Abiraterone acetate 250 mg/1 | TabletOral | Dr. Reddys Laboratories Inc | 75907-224 |